Skip to main content

Advertisement

SpringerLink
Log in

Is adaptation or transformation needed? Active nanomaterials and risk analysis

  • Research Paper
  • Published:
Journal of Nanoparticle Research Aims and scope Submit manuscript

Abstract

Nanotechnology has been a key area of funding and policy for the United States and globally for the past two decades. Since nanotechnology research and development became a focus and nanoproducts began to permeate the market, scholars and scientists have been concerned about how to assess the risks that they may pose to human health and the environment. The newest generation of nanomaterials includes biomolecules that can respond to and influence their environments, and there is a need to explore whether and how existing risk-analysis frameworks are challenged by such novelty. To fill this niche, we used a modified approach of upstream oversight assessment (UOA), a subset of anticipatory governance. We first selected case studies of “active nanomaterials,” that are early in research and development and designed for use in multiple sectors, and then considered them under several, key risk-analysis frameworks. We found two ways in which the cases challenge the frameworks. The first category relates to how to assess risk under a narrow framing of the term (direct health and environmental harm), and the second involves the definition of what constitutes a “risk” worthy of assessment and consideration in decision making. In light of these challenges, we propose some changes for risk analysis in the face of active nanostructures in order to improve risk governance.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

(Adapted from Renn 1992)

Fig. 5

(Adapted from Zhang et al. 2014)

Fig. 6

(Adapted from Grove et al. 2013)

Fig. 7

(Adapted from Brown et al. 2013)

Fig. 8

(Adapted from Brown et al. 2013)

Fig. 9

Similar content being viewed by others

References

  • Anderson M et al (2004) Risk assessment for invasive species. Risk Anal 24(4):787–793

    Article  Google Scholar 

  • Arts JHE et al (2015) A decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping). Regul Toxicol Pharmacol 71(2):S1–S27

    Article  Google Scholar 

  • Barben D, Fisher E, Selin C, Guston DH (2008) Anticipatory governance of nanotechnology: foresight, engagement, and integration. In: Hackett EJ, Amsterdamska O, Lynch ME, Wajcman J (eds) The New Handbook of Science and Technology Studies. MIT Press, Cambridge, pp 979–1000

  • Blatch GL, Lässle M (1999) The tetratricopeptide repeat: a structural motif mediating protein-protein interactions. Bioessays 21:932–939

    Article  Google Scholar 

  • Brown PK, Qureshi AT, Moll AN, Hayes DJ, Monroe WT (2013) Silver nanoscale antisense drug delivery system for photoactivated gene silencing. ACS Nano 7(4):2948–2959

    Article  Google Scholar 

  • Byrd DM, Cothern CR (2005) Introduction to risk analysis: a systematic approach to science-based decision making. Ecological risk analysis. Government Institutes Press, Lanham, pp 311–327

    Google Scholar 

  • Castellano L, Stebbing J (2013) Deep sequencing of small RNAs identifies canonical and non-canonical miRNA and endogenous siRNAs in mammalian somatic tissues. Nucleic Acids Res 41:3339–3351

    Article  Google Scholar 

  • EPA (1998) Guidelines for ecological risk assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, EPA/630/R095/002F

  • Ezell BC et al (2010) Probabilistic risk assessment and terrorism risk. Risk Anal 30(4):575–589

    Article  Google Scholar 

  • FDA (2015a) Food and drug administration. Biotechnology consultation—note to file biotechnology notification file no. 132. http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm436168.htm

  • FDA (2015b) Food and drug administration. Biotechnology consultation—note to file biotechnology notification file no. 141. http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm436173.htm

  • Fedorov Y, Anderson EM, Birmingham A, Reynolds A, Karpilow J, Robinson K et al (2006) Off-target effects by siRNA can induce toxic phenotype. RNA 12(7):1188–1196

    Article  Google Scholar 

  • Fjeld R et al (2007) Chapter 11. Dose-response and risk characterization. Quantitative environmental risk analysis for human health. Wiley, Hoboken, pp 245–282

    Book  Google Scholar 

  • Funtowicz, S, Ravetz J (2008) Post-normal science. In: Cleveland CJ (ed) Encyclopedia of earth. Environmental Information Coalition, National Council for Science and the Environment, Washington, DC

  • Gavankar S et al (2012) Life cycle assessment at nanoscale: review and recommendations. Int J Life Cycle Assess 17:295–303

    Article  Google Scholar 

  • Grimm D (2011) The dose can make the poison: lessons learned from adverse in vivo toxicities caused by RNAi overexpression. Silence 2(1):1–6

    Article  Google Scholar 

  • Grove TZ, Forster J, Pimienta G, Dufresne E, Regan L (2012) A modular approach to the design of protein-based smart gels. Biopolymers 97(7):508–517

    Article  Google Scholar 

  • Grove TZ, Regan L, Cortajarena AL (2013) Nanostructured functional films from engineered repeat proteins. J R Soc Interface 10(83):20130051

    Article  Google Scholar 

  • Gu HZ, Chao J, Xiao SJ, Seeman NC (2010) A proximity-based programmable DNA nanoscale assembly line. Nature 465:202–205

    Article  Google Scholar 

  • Guston DH (2014) Understanding ‘anticipatory governance’. Soc Stud Sci 44(2):218–242

    Article  Google Scholar 

  • Guston D, Sarewitz D (2002) Real-time technology assessment. Technol Soc 23:93–109

    Article  Google Scholar 

  • Helwak A, Kudla G, Dudnakova T, Tollervey D (2013) Mapping the human miRNA interactome by CLASH reveals frequent noncanonical binding. Cell 153:654–665

    Article  Google Scholar 

  • IRGC (2006) White paper on risk governance: towards an integrative approach. International Council on Risk Governance, Geneva. http://www.irgc.org

  • IRGC (2007) Nanotechnology risk governance. Policy brief. International Risk Governance Council, Geneva. http://www.irgc.org

  • Katoch R, Sethi A, Thakur N, Murdock LL (2013) RNAi for insect control: current perspective and future challenges. Appl Biochem Biotechnol 171(4):847–873

    Article  Google Scholar 

  • Kaushik R, Balasubramanian R (2014) A comparative toxicity evaluation of Escherichia coli-targeted ssDNA and chlorine in HepG2 cells. Water Res 48:519–528

    Article  Google Scholar 

  • Kuzma J (2010) Nanotechnology in animal production: upstream assessment of applications. Livest Sci 130:14–24

    Article  Google Scholar 

  • Kuzma J, Besley J (2008) Ethics of risk analysis and regulatory review: From bio- to nanotechnology. Nanoethics 2(2):149–162

    Article  Google Scholar 

  • Kuzma J, Verhage P (2006) Nanotechnology in agriculture and food production. Project on emerging nanotechnologies PEN4. Woodrow, Washington, DC

    Google Scholar 

  • Kuzma J, Romanchek J, Kokotovich A (2008) Upstream oversight assessment for agrifood nanotechnology. Risk Anal 28:1081–1098

    Article  Google Scholar 

  • Lin C, Rinker S, Wang X, Liu Y, Seeman NC, Yan H (2008) In vivo cloning of artificial DNA nanostructures. Proc Natl Acad Sci 105(46):17626–17631

    Article  Google Scholar 

  • Lin C, Liu Y, Yan H (2009) Designer DNA nanoarchitectures. Biochemistry 48(8):1663–1674

    Article  Google Scholar 

  • MacPhail RC et al (2013) Assessing nanoparticle risk poses prodigious challenges. WIREs Nanomed Nanobiotechnol 5:374–387

    Article  Google Scholar 

  • Maynard A et al (2011) The new toxicology of sophisticated materials: nanotoxicology and beyond. Toxicol Sci 120(S1):S109–S129

    Article  Google Scholar 

  • Miller G, Wickson F (2015) Risk analysis of nanomaterials: exposing nanotechnology’s naked emperor. Rev Policy Res 32(4):485–512

    Article  Google Scholar 

  • NRC (1983) Risk assessment in the federal government: managing the process. National Academies Press, Washington, DC

    Google Scholar 

  • NRC (1996) Understanding risk. National Academies Press, Washington, DC

    Google Scholar 

  • NRC (2009) Science and decisions. National Academies Press, Washington, DC

    Google Scholar 

  • NSF (2006) Active nanostrutures and nanosystems (ANN). National Science Foundation Solicitation, NSF 06-595

  • Olsen SI et al (2001) Life cycle impact assessment and risk assessment of chemicals—a methodological comparison. Environ Impact Assess Rev 21(4):385–404

    Article  Google Scholar 

  • Paradise J, Tisdale AW, Hall RF, Kokkoli E (2009) Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology. J Law Med Ethics 37(4):598–624

    Article  Google Scholar 

  • Parkin R (2007) Microbial risk assessment. Chapter 11. In: Robson MG, Toscano WA (eds) Risk assessment for environmental health. Wiley, San Francisco, pp 285–313

    Google Scholar 

  • Petrick JS, Brower-Toland B, Jackson AL, Kier LD (2013) Safety assessment of food and feed from biotechnology-derived crops employing RNA-mediated gene regulation to achieve desired traits: a scientific review. Regul Toxicol Pharmacol 66(2):167–176

    Article  Google Scholar 

  • Renn O (1992) Concepts of risk: a classification. Chapter 3. In: Krimsky S (ed) Social theories of risk. Praeger, Westport, pp 53–79

    Google Scholar 

  • Roco M (2004) Nanoscale science and engineering: unifying and transforming tools. AIChE J 50:890–897

    Article  Google Scholar 

  • Selness AR, Vennette RC (2006) Minnesota pest risk assessment: Emerald Ash Borer. MN Department of Agriculture Publication number: PRA-APLA-001

  • Sharp P (2001) RNA interference—2001. Genes Dev 15:485–490

    Article  Google Scholar 

  • Shatkin JA (2008) Informing environmental decision making by combining life cycle assessment and risk analysis. J Ind Ecol 12(3):278–281

    Article  Google Scholar 

  • Shi Y, Zhang J, Jiang M, Zhu L, Tan H, Lu B (2010) Synergistic genotoxicity caused by low concentration of titanium dioxide nanoparticles and p,p′-DDT in human hepatocytes. Environ Mol Mutagen 51(3):192–204

    Google Scholar 

  • Stirling A (2007) Risk, precaution and science: towards a more constructive policy debate. EMBO Rep 8(4):309–315

    Article  Google Scholar 

  • Subramanian V, Youtie J et al (2010) Is there a shift to “active nanostructures”? J Nanopart Res 12(1):1–10

    Article  Google Scholar 

  • USDA (2014) Okanagan specialty fruits Inc.’s petition (10-161-01p) for determination of non-regulated status of non-browning arcticTM apple events GD743 and GS784. https://www.aphis.usda.gov/brs/aphisdocs/10_16101p_dea.pdf

  • Wang T et al (2011) Self-replication of information-bearing nanoscale patterns. Nature 478:225–228

    Article  Google Scholar 

  • Yang J, Hirschi KD, Farmer L (2015) Dietary RNAs: New stories regarding oral delivery. Nutrients 7:3184–3199

    Article  Google Scholar 

  • Yu N, Christiaens O, Liu J, Niu J, Cappelle K, Caccia S et al (2013) Delivery of dsRNA for RNAi in insects: an overview and future directions. Insect Sci 20:4–14

    Article  Google Scholar 

  • Zhang X, Zhang J, Zhu KY (2010) Chitosan/double-stranded RNA nanoparticle-mediated RNA interference to silence chitin synthase genes through larval feeding in the African malaria mosquito (Anopheles gambiae). Insect Mol Biol 19:683–693

    Article  Google Scholar 

  • Zhang L et al (2012) Exogenous plant MIR168a specifically targets mammalian LDLRAP1: evidence of cross-kingdom regulation by microRNA. Cell Res 22:107–126

    Article  Google Scholar 

  • Zhang F et al (2014) Structural DNA nanotechnology: state of the art and future perspective. J Am Chem Soc 136:11198–11211

    Article  Google Scholar 

Download references

Acknowledgments

This work was supported by the National Science Foundation (NSF) Award to the Center for Nanotechnology in Society at ASU (Guston) and Ndnano at Notre Dame (Eggleson) #1235693 and by the Genetic Engineering and Society Center at North Carolina State University (www.research.ncsu.edu/ges). The findings and observations contained in this article are those of the authors and do not necessarily reflect the views of the National Science Foundation.

Author information

Authors and Affiliations

  1. School of Public and International Affairs and Genetic Engineering and Society Center, North Carolina State University, Raleigh, USA

    Jennifer Kuzma

  2. School of Public and International Affairs, North Carolina State University, Raleigh, USA

    John Patrick Roberts

Authors
  1. Jennifer Kuzma
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. John Patrick Roberts
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Jennifer Kuzma.

Additional information

Guest Editors: Kathleen Eggleson, David H. Guston

This article is part of the Special Focus on Anticipatory Governance of Next Generation Nanotechnology

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Kuzma, J., Roberts, J.P. Is adaptation or transformation needed? Active nanomaterials and risk analysis. J Nanopart Res 18, 215 (2016). https://doi.org/10.1007/s11051-016-3506-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s11051-016-3506-y

Keywords

Search

Navigation